Catheter securement device

ABSTRACT

A catheter securement device holds a medical article such as a catheter hub or a connector fitting in position upon the body of a patient and at least inhibits longitudinal movement of the medical article. The securement device includes a retainer and at least one anchor pad. The retainer forms a central channel into which at least a portion of the medical article is inserted. The retainer includes at least one abutment that can abut against a contact point or surface on the medical article. The abutment, in conjunction with a second abutment and/or a tapering shape of the central channel, inhibits motion of the medical article in proximal and distal directions through the central channel. For this purpose, the abutment surface(s) can lie either within or outside the channel.

RELATED APPLICATIONS

This application is a divisional of U.S. application patent Ser. No.10/642,445, filed Aug. 15, 2003 now U.S. Pat. No. 7,014,627, whichclaims priority under 35 U.S.C. §119(e) to U.S. Provisional PatentApplication Ser. No. 60/404,354 (filed Aug. 15, 2002), 60/411,127 (filedSep. 16, 2002), 60/414,999 (filed Sep. 30, 2002), 60/418,389 (filed Oct.11, 2002), and 60/454,430 (filed Mar. 11, 2003), all of which are herebyexpressly incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a securement system used to attach a medicalline to a patient.

2. Description of the Related Art

It is common in the treatment of patients to utilize catheters tointroduce fluids and medications directly into the patient or towithdraw fluids from the patient. Often, it becomes desirable tomaintain such catheterization over an extended period of time during thetreatment of a patient. In order to keep the catheter or other medicalline properly positioned for the duration of treatment, the catheter ormedical line can be secured to the patient in a variety of ways. Mostcommonly, this involves taping the catheter or medical line to thepatient.

Securing a catheter with tape upon the patient traditionally has certaindrawbacks. The use of tape at the insertion site can retain dirt orother contaminant particles, potentially leading to infection of thepatient. Tape also fails to limit catheter motion and, therefore,contributes to motion related complications like phlebitis, infiltrationand catheter migration. Additionally, removal of taped dressings canitself cause undesired motion of the catheter upon the patient.

Taped dressings also require periodic changes. The frequent, oftendaily, removal and reapplication of adhesive tape to the skin of thepatient can excoriate the skin in the area around the dressing. Suchrepeated applications of tape over the catheter or medical line canadditionally lead to the build up of adhesive residue on the outersurface of the catheter or medical line. This residue can result incontaminants adhering to the catheter itself, increasing the likelihoodof infection of the insertion site. This residue can also make thecatheter or medical line stickier and more difficult to handle forhealthcare providers.

SUMMARY OF THE INVENTION

The systems and methods of the present invention have several features,no single one of which is solely responsible for its desirableattributes. Without limiting the scope of this invention as expressed bythe claims which follow, its more prominent features will now bediscussed briefly. After considering this discussion, and particularlyafter reading the section entitled “Detailed Description of thePreferred Embodiments” one will understand how the features of thisinvention provide several advantages over traditional cathetersecurement systems.

One aspect of the present invention is a medical line securement systemthat comprises a medical article, at least one anchor pad including alower adhesive surface configured to attach to an epidermal layer of apatient, and a retainer. The retainer comprising a body member having achannel formed therethrough about a channel axis, the channel beingconfigured to retain at least a portion of the medical article andhaving a longitudinal access opening disposed on an underside of thebody member to allow at least ingress of the portion of the medicalarticle into the channel. The retainer further comprising at least oneabutment extending generally normal to the channel axis and configuredto inhibit longitudinal movement of the medical article and at least onesupport disposed on the underside of the retainer and to a side of theaccess opening opposite the channel axis, the support attached to theanchor pad.

Another aspect of the invention is a retainer configured for use with amedical article. The retainer comprises a body member which comprising achannel formed through the body member, the channel being configured toretain at least a portion of the medical article and having alongitudinal access opening disposed on an underside of the body memberto allow at least ingress of the medical article into the channel. Thebody member further comprising at least one abutment extending generallynormal to an axis of the inverted channel and configured to inhibitlongitudinal movement of the medical article and at least one supportdisposed on the underside of the retainer and to a side of the accessopening opposite the channel axis.

Another aspect of the invention is a retainer that is configured for usewith a medical article. The retainer comprises a body member whichcomprises a channel formed through the body member, the channel beingconfigured to retain at least a portion of the medical article andhaving a longitudinal access opening disposed on an underside of thebody member to allow ingress of the portion of the medical article intothe channel. The body member further comprising at least one abutmentextending generally normal to an axis of the channel and configured toinhibit longitudinal movement of the medical article and means forholding the medical article away from a patient's skin.

Yet another aspect of the invention is a retainer that is configured foruse with a medical article that comprises a radially extending member.The retainer comprises a body member having proximal and distal ends andfurther comprises a channel formed through the body member, the channelbeing configured to retain at least a portion of the medical article andhaving a longitudinal access opening disposed on an underside of thebody member to allow at least ingress of the medical article into thechannel. The body member further comprises at least one slot disposedbetween the proximal and distal ends of the body member and configuredto receive the radially extending member and a stop member extendinginto a portion of the at least one slot such that when the medicalarticle is inserted into the channel and rotated in a first directionaround the axis of the channel, the radially extending member slideswithin the slot until the radially extending member contacts the stopmember.

Another aspect of the invention is a method of securing a medicalarticle to a patient. The method comprises providing a medical article,providing a retainer having a channel formed therethrough, the channelbeing configured to receive and retain the medical article, and at leastone abutment extending generally normal to the channel, and positioningthe retainer over the medical article. The method further comprisespressing the medical article into the channel through an opening formedon the underside of the retainer, abutting the medical article againstthe abutment to inhibit longitudinal motion of the medical articlerelative to the retainer in at least one direction, and after pressingthe article into the body member, adhering the retainer relative to apatient's skin.

Still another aspect of the invention is a medical line securementsystem that comprises a medical article having a connector and aretainer. The retainer comprises a body member having a channel formedtherethrough, the channel being configured to retain at least a portionof the medical article and having a longitudinal access opening disposedon an underside of the body member to allow ingress of the portion ofthe medical article into the channel and at least one abutment extendinggenerally normal to an axis of the channel and configured to inhibitlongitudinal movement of the medical article. The retainer furthercomprises at least one support surface disposed on the underside of theretainer and to a side of the access opening opposite the channel axisand wherein an overall length of the retainer is less than a length ofthe medical article.

A further aspect of the invention is a retainer configured for use witha medical article. The retained comprises a body member which comprisesa channel formed therethrough, the channel being configured to retain aportion of the medical article and having a longitudinal access openingdisposed on an underside of the body member to allow ingress of themedical article into the channel. The body member further comprising atleast one abutment extending generally normal to an axis of the channeland configured to inhibit longitudinal movement of the medical articleand at least one support disposed on the underside of the retainer andto a side of the access opening opposite the channel axis, wherein adistance between the at least one support and the axis of the channelprevents contact between the medical article and a patient's skin whenthe retainer is placed upon the patient's skin.

A still further aspect of the invention is a retainer configured for usewith a medical article. The retainer comprises a body member whichcomprises a channel formed therethrough, the channel being configured toretain the medical article and having a longitudinal access openingdisposed on an underside of the body member to allow ingress of themedical article. The body member further comprises at least one abutmentextending generally normal to an axis of the channel and configured toinhibit longitudinal movement of the medical article and at least onesupport disposed on the underside of the retainer and to one side of theaccess opening opposite the channel axis, wherein the support surfaceprovides a mounting surface for attachment of the retainer to apatient's skin, and wherein the mounting surface is angled relative tothe longitudinal access opening to define an incident angle between theaxis of the channel and the patient's skin.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the securement device configured inaccordance with a preferred embodiment of the present invention.

FIG. 2 is a top plan view of the securement device of FIG. 1 thatincludes a retainer and anchor pads.

FIG. 3 is a top plan view of a right anchor pad of FIG. 2.

FIG. 4 is a top plan view of a left anchor pad of FIG. 2.

FIG. 5 is a top plan view of the retainer of FIG. 2.

FIG. 6 is a front side view of the retainer of FIG. 5.

FIG. 7 is a side view of the retainer of FIG. 5.

FIG. 8 is a side view of the retainer of FIG. 5.

FIG. 9 is a cross-section view of the retainer taken along section 9-9of FIG. 5.

FIG. 10 is a cross-section view of the retainer taken along section10-10 of FIG. 5.

FIG. 11 is a cross-section view of the retainer taken along section11-11 of FIG. 5 and illustrates an optional wall or stop member in thepreferred embodiment that extends into the path of the one or more slotsin the region of the mounting wing 210(b).

FIG. 12 is a bottom plan view of the retainer of FIG. 5 and illustratesthat the distance between the side mounting wings varies in the regionof the retainer.

FIG. 13 is a rear side view of the retainer of FIG. 5.

FIG. 14A is a perspective view of a retainer configured in accordancewith another preferred embodiment in which the inverted channel has atapering distal section, a generally constant size proximal section andan abutment surface facing distally between the proximal and distalsections of the channel.

FIG. 14B is a top plan view of the retainer of FIG. 14B and illustratesproximal and distal sections of the channel.

FIG. 15A is a perspective view of an example of a connector fitting witha spin nut and of a catheter hub with which the securement device ofFIG. 1 can be used.

FIG. 15B is a perspective view of the connector fitting of FIG. 15A withthe spin nut secured in the forward position and secured to the catheterhub.

FIG. 16 is an exploded, perspective view of the connector fittingsecured to the catheter hub of FIG. 15B, both aligned with the anchorpad and the retainer of FIG. 1.

FIG. 17 is an exploded, perspective view of the connector fittingsecured to the catheter hub of FIG. 15B, with the catheter hub beinginserted into the retainer of FIG. 1.

FIG. 18 is a perspective view of the catheter hub secured to thesecurement device of FIG. 1.

FIG. 19 is a perspective view of a securement device configured inaccordance with another preferred embodiment of the present invention.

FIG. 20 is a perspective view of a connector fitting secured to acatheter hub, with the connector fitting having a first collar locatedbetween a second collar and a spin nut.

FIG. 21 is a perspective view of another connector fitting secured to acatheter hub, with the connector fitting having a radially extendingtab.

FIG. 22 is an exploded, perspective view of the connector fitting andthe catheter hub of FIG. 20, the collar of the connector fitting beingaligned with the anchor pad and the retainer of FIG. 19.

FIG. 23 is an exploded, perspective view of the connector fitting andthe catheter hub of FIG. 15B, the elongated body of the connectorfitting being aligned with the anchor pad and the retainer of FIG. 19.

FIG. 24 is an exploded, perspective view of the connector fitting andthe catheter hub of FIG. 15B, the collars of the connector fitting beingaligned with the anchor pad and the retainer of FIG. 19.

FIG. 25 is an exploded, perspective view of the connector fitting andthe catheter hub of FIG. 20, a portion of the elongated body of theconnector fitting being aligned with the anchor pad and the retainer ofFIG. 19.

FIG. 26 is an exploded, perspective view of the connector fitting andthe catheter hub of FIG. 20, the connector fitting being aligned with ananchor pad and a retainer of the securement device of FIG. 1.

FIG. 27A is a rear perspective view of a retainer configured inaccordance with another preferred embodiment of the present invention.

FIG. 27B is a front perspective view of the retainer of FIG. 27A.

FIG. 27C is a top plan view of the retainer of FIG. 27A.

FIG. 27D is a rear elevational view of the retainer of FIG. 27C.

FIG. 27E is a bottom plan view of the retainer of FIG. 27D.

FIG. 27F is a side elevational view of the retainer of FIG. 27A.

FIG. 27G is a cross-sectional view of the retainer of FIG. 27F takenalong line 27G-27G.

FIG. 27H is a front view of the retainer of FIG. 27C.

FIG. 27I is a cross-sectional view of the retainer of FIG. 27D takenalong line 27I-27I.

FIG. 27J is a side elevational view of the retainer of FIG. 27F engagewith a connector fitting that is secured to a catheter hub.

FIG. 28 is an exploded, perspective view of the connector fitting andthe catheter hub of FIG. 20, the connector fitting being aligned with ananchor pad and a retainer of the securement device of FIG. 27A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description and the accompanying figures, which describeand show the preferred embodiments, are made to demonstrate severalpossible configurations that a securement system can take to includevarious aspects and features the invention. The illustrated embodimentsare shown in use with either one or both of an illustrative example of acatheter hub and an illustrative example of a connector fitting with aspin nut for connection to the catheter hub. The illustration of thesecurement device in this context is not intended to limit the disclosedaspects and features of the invention to the specified embodiments or tousage only with the illustrated connector or hub. Those of skill in theart will recognize that the disclosed aspects and features of theinvention are not limited to any particular embodiment of a securementsystem, and securement systems, which include one or more of theinventive aspects and features herein described, can be designed for usewith a variety of medical articles.

To assist in the description of these components of the securementsystem, the following coordinate terms are used (see FIG. 1). A“longitudinal axis” is generally parallel to a portion of the catheterhub, the connector fitting or other medical article retained by thesecurement system, as well as parallel to the axis of a channel of theretainer, through which the medical article extends. A “lateral axis” isnormal to the longitudinal axis. A “transverse axis” extends normal toboth the longitudinal and lateral axes. In addition, as used herein,“the longitudinal direction” refers to a direction substantiallyparallel to the longitudinal axis; “the lateral direction” refers to adirection substantially parallel to the lateral axis; and “thetransverse direction” refers to a direction substantially parallel tothe transverse axis. The term “axial” as used herein refers to the axisof the channel or connector fitting, and therefore is substantiallysynonymous with the term “longitudinal” as used herein. Also, the terms“proximal” and “distal”, which are used to describe the presentsecurement system, are used consistently with the description of theexemplary applications (i.e., the illustrative examples of the useapplications). Thus, proximal and distal are used in reference to thecenter of the patient's body. The terms “upper,” “lower,” “top,”“bottom,” “underside,” “upperside” and the like, which also are used todescribe the present securement system, are used in reference to theillustrated orientation of the embodiment. For example, the term“upperside” is used to describe the portion of the retainer that islocated above a lateral axis that passes through the axis of thechannel. The term “underside” is used to describe the portion of theretainer that is located below a lateral axis that passes through theaxis of the channel. Brief introductions to some of the features, whichare common to the described embodiments of the securement systems, arenow described. In the illustrated embodiment, the arrows on thesecurement device point in the direction toward the insertion site(i.e., in the proximal direction).

The preferred embodiments of the present invention advantageouslyprovide a medical line securement system for securing a medical articleto a patient. The medical article preferably has an elongated body. Theelongated body cooperates with a retainer to arrest movement of themedical article in longitudinal, lateral, and transverse directions whenplaced within the retainer.

In each of the embodiments described below, the retainer has a bodymember which includes an inverted channel formed therethrough. Theinverted channel has a longitudinal access opening located on anunderside of the retainer to allow ingress or egress of the medicalarticle. The medical article is installed or removed from the undersideof the retainer via this access opening. Such an arrangement allows themedical provider to align at least a portion of the medical article withthe retainer prior to fixing the retainer to the patient's skin. In thisway, the inverted channel retains a portion of the medical article.

The retainer includes at least one abutment (preferably an abutmentsurface) that cooperates with at least one contact point or surface onthe medical article. The one or more abutments of the retainer extendgenerally normal to the axis of the channel and can be, for example, butwithout limitation a surface, a wall of a slot, a ridge, a protuberance,or like structures. The abutment cooperates with the one or more contactpoints or surfaces of the medical article to inhibit longitudinalmovement of the medical article through the channel. For example, theabutment could be a surface on the distal end of the retainer that actsagainst at least a portion of a radially extending member or spin nut ofthe medical article. In this way, the medical article will be limited init proximal movement (i.e., movement toward the patient) once theradially extending member contacts or abuts against the distal end ofthe retainer.

The retainer of each embodiment described below further includes atleast one support that is preferably disposed on the underside of theretainer at a position lower than the access opening. With thisconstruction, the retainer holds the retained portion of medical articleaway from the patient's skin, when the retained portion is positionedwithin the retainer channel, to avoid chaffing or excoriating the skin.The support in each of the illustrated embodiments includes left andright mounting wings that are integral with the body member and areattached to left and right anchor pads. The lower surfaces of the leftand right anchor pads attach to the patient's skin.

The retainer and anchor pad(s) also can have other constructions inorder to inhibit contact between the skin and the retainer, as well asbetween the skin and the retained portion of the medical article. Forexample, the anchor pads can be thicker, in which case the mountingwings can be located higher on the retainer body.

To facilitate a complete understanding of the embodiment, the remainderof the detailed description describes the securement system withreference to the figures, wherein like elements among the embodimentsare referenced with like numerals throughout the following description.

FIG. 1 is a perspective view of a securement device 100 configured inaccordance with an embodiment of the present invention and FIG. 2 is atop plan view of the securement device 100 of FIG. 1. As shown in FIGS.1 and 2, the illustrated securement device 100 comprises three maincomponents: two anchor pads 110(a), 110(b) and a retainer 120. Theillustrated retainer 120 includes a left footing/mounting wing 210(a)and right footing/mounting wing 210(b). Each mounting wing is disposedupon the respective one of the anchor pads 110(a), 110(b). The mountingwings 210(a), 210(b) extend in a lateral direction away from a center ofthe retainer 120.

As noted above, the securement device 100 can form a component of acatheterization or securement system that also includes one or moremedical articles, such as connector fittings, catheters, hubs, catheteradaptors, fluid supply lines, or other articles suitable for securementvia the anchor pads and retainer. An opening in the retainer 120 isaligned with the medical article. The medical article is insertedbetween the anchor pads 110(a), 110(b), through the opening, and intothe retainer 120. The anchor pads 110(a), 110(b) are then secured to theskin of the patient, generally by an adhesive disposed upon the bottomsurface of the pads. In this way, the retainer 120 secures the medicalarticle to the patient. Thus, the retainer at least restricts, if notprevents, lateral and transverse movement of the retained section of themedical article. Additional features of the securement device 100 canrestrict, if not prevent, longitudinal and rotational movement of theretained section of the medical article. The embodiment illustrated ispreferably for use with a catheter adapter or hub, as described withreference to FIGS. 15A and 15B. The embodiments of the anchor pad andthe retainer are described in more detail below.

Anchor Pad

FIGS. 3 and 4 illustrate the anchor pads 110(b), 110(a), respectively,apart from the rest of the securement device 110 shown in FIG. 2. Thegeneral structure of each anchor pads 110(a), 110(b) comprises agenerally rectangular shape with a scalloped region 112 located at acorner of each anchor pad. The scalloped configuration eases the processof aligning the securement device 100 with a catheter insertion site inthe patient's skin. Although only a single shape of the anchor pad isillustrated in FIGS. 3 and 4, those of skill in the art will recognizethat a variety of shapes can be used.

Each anchor pad 110 desirably comprises a laminate structure with anupper plastic, paper or foam layer (e.g., closed-cell polyethylene foam)and a lower adhesive layer. The lower adhesive layer constitutes a lowersurface 160 of the anchor pad. The lower surface 160 desirably is amedical-grade adhesive and can be either diaphoretic or nondiaphoretic,depending upon the particular application. Such foam with an adhesivelayer is available commercially from Avery Dennison of Painsville, Ohio.While not illustrated, the anchor pads 110(a), 110(b) can include sutureholes in addition to the adhesive layer to further secure the anchor padto the patient's skin.

In other variations, a hydrocolloid adhesive or zinc oxide-basedadhesive can advantageously be used upon the anchor pads 110(a), 110(b)for attaching the anchor pads to the skin of the patient. Thehydrocolloid or zinc oxide-based adhesive can be used either alone or incombination with another medical grade adhesive (e.g., in combinationwith the adhesive available from Avery Dennison). Hydrocolloid and zincoxide-based adhesives have less of a tendency to excoriate the skin of apatient when removed. This can be particularly important for patientswhose skin is more sensitive or fragile, such as neonates and those witha collagen deficiency or other skin related condition.

In another variation, each anchor pad 110(a), 110(b) comprises alaminate structure with an upper woven layer and a lower adhesive layer.The upper layer can be polyester or other suitable polymer or textilematerials. One particular suitable material is a woven polyesteravailable commercially under the name “Tricot” from Tyco. The loweradhesive layer constitutes the lower surface 160 of the anchor pad. Thelower surface desirably is a medical-grade adhesive and can be eitherdiaphoretic or nondiaphoretic, depending upon the particularapplication.

A surface of the upper foam layer constitutes an upper surface 170 ofthe anchor pads 110(a), 110(b). The upper surface 170 can be roughenedby corona-treating the foam with a low electric charge. The roughened orporous upper surface can improve the quality of the adhesive joint(which is described below) between the mounting wings 210 and the anchorpads 110. In a further variation, the flexible anchor pad can comprisean upper paper or other woven or nonwoven cloth or plastic layer in lieuof a roughened upper foam surface.

The anchor pads 110(a), 110(b) preferably are arranged with respect tothe retainer 120 such that the tip of the medical article does notextend beyond the front edge of the mounting wings 210 when the medicalarticle is properly inserted within the retainer 120. The healthcareprovider can be instructed to generally align the medical article tipwith the front edges of the anchor pads 110(a), 110(b) before insertingthe medical article into the retainer 120.

As illustrated in FIG. 3, a removable paper or plastic release liner 180desirably covers the adhesive lower surface 160 before use. The liner180 preferably resists tearing and desirably is divided into a pluralityof pieces to ease attachment of the pad to a patient's skin.

The liner 180 comprises a folded over portion to define a pull tab 190(see FIG. 1). The pull tab can be utilized to remove the paper orplastic release liner 180 from their adhesive lower surface 160 beforeuse. A healthcare provider uses the pull tab 190 by grasping and pullingon it so that the liner 180 is separated from the lower surface 160. Thepull tab 190 overcomes any requirement that the healthcare provider pickat a corner edge or other segment of the liner in order to separate theliner from the adhesive layer.

The pull tab 190 of course can be designed in a variety ofconfigurations. For example, the pull tab 190 can be located along acenter line of the anchor pad 110; or alternatively, the pull tab can belocated along any line of the anchor pad 110 in order to ease theapplication of the anchor pad onto the patient's skin at a specificsite. For example, an area of a patient's skin with an abrupt bend, suchas at a joint, can require that the pull tab 190 be aligned toward oneof the lateral ends of the anchor pad 110 rather than along the centerline. In the embodiment illustrated in FIGS. 3 and 4, the pull tab 190extends from a bottom surface of the anchor pads 110(a), 110(b) andalong an outer line 195.

The fold that forms the pull tab 190 preferably occurs laterally beyondthe inner (medial) edge on each anchor pad 110(a), 110(b), as best seenin FIG. 2, rather than at the inner edge of the anchor pad 110(a),110(b). Thus, the spacing between the folds of the release liners 180 isless than the spacing between the inner edges of the anchor pads 110(a),110(b). The projection of the release linear beyond the anchor pad inneredge provides an area onto which any adhesive, which is used to attachthe retainer to the anchor pad, can run while lessening the occurrenceof such adhesive contacting the fold. Cracks often occur at the fold andpresence of adhesive in such cracks can create delimitation of therelease liner and incomplete removal of the release linear when peeledaway from the corresponding anchor pad 110(a), 110(b).

Additionally, the distal side of each release linear is cut to increasea “view window” through which a healthcare provider can see whenaligning the retainer over the medical article (e.g., the catheter huband/or the connector fitting). Preferably, the resulting relieforiginates from the inner edge of the release linear generally at aright angle thereto and then transitions into a shape that generallymatches the shape of the adjacent region of corresponding anchor pad110(a), 110(b). The initial right-angle cut of this relief reducesinstances of the release linear ripping when properly pulled in thelateral direction away from the retainer 120.

Retainer

An embodiment of the retainer 120 is described with reference to FIGS.5-13. FIG. 5 is a top plan view of the retainer 120 which limitsrotation of an installed catheter hub as well as arrests movement of thecatheter hub in the longitudinal, lateral and transverse directions.FIG. 6 is a front side view of the retainer 120 from FIG. 5 andillustrates a body member 130 and footings/side mounting wings 210(a),210(b) that extend in a lateral direction from either side of the bodymember. As shown in FIGS. 7 and 8, the body member 130 is elongated inthe longitudinal direction and comprises a generally parallelepipedshape. It is advantageous for the longitudinal dimension of the bodymember 130 to be sufficiently long to provide stability to the retainedportion of the medical article along its length. In this way, thelongitudinal length of the retained portion is sufficient to inhibit therocking of the medical article within the retainer 120. Also, thelateral dimension of the body member 130 of the retainer desirablyallows the healthcare provider to easily and naturally grip the bodymember.

With reference to FIG. 6, the inner side of the body member 130 facestowards the patient's skin when in use and preferably defines aninverted central channel 140. The inverted channel 140 extends on theunderside of the body member 130 in a longitudinal direction forreceiving a section of the catheter hub in the illustrated embodiment.

The channel 140 is capable of receiving a portion or length of themedical article and is generally configured to house, to preferablygrip, and to secure this portion of the medical article. In theillustrated embodiment (see FIGS. 5 through 8), the central channel 140has a generally semi-circular cross-sectional shape. An inner surfacecontour of the central channel 140 preferably is selected depending onthe geometry of the portion of the medical article to be retained. Forexample, in a retainer 120 that is configured to retain a portion of amedical article that has a constant outer diameter, the central channel140 preferably has a constant radius along its length. In contrast, in aretainer 120 configured to retain a portion of a medical article thathas a tapering outer surface, the central channel 140 preferably has atapering inner surface and a radius that varies along the channellength. Additional embodiments of the central channel 140 of theretainer can comprise a plurality of different radii and/or taperingregions. For example, as illustrated in FIGS. 14A and 14B, the channel140 can have two sections: a first proximal section 140(a) have agenerally uniform cross-sectional size along its length while a seconddistal section 140(b) has a tapering shape along its length. An abutmentwall forms a transition between these two sections of the channel. Thesesections 140(a), 140(b) of the channel 140 can also both be tapered orstraight (i.e., have a generally uniform radius along the length of thesection) or the distal section can be straight and the proximal sectioncan be tapered. In this way, the size and shape of the central channel140 can be chosen to match or to approximate the size and shape of themedical article or portion thereof, e.g., the catheter hub, to beretained. By matching the inner surface contour of the central channel140 to the outer surface of the secured portion of a medical article, amore effective securement may be achieved. In addition or in thealternative, effective securement can also be achieved by the engagementof one or more abutment surface of the retainer with one or more contactsurfaces on the medical article. Each abutment surface can cooperatewith a contact surface on the medical article to inhibit movement of themedical article relative to the retainer. Exemplary abutment surfacesand contact surfaces are described below with reference to FIGS. 16-18.

Although the central channel 140 can be formed in various shapesdepending upon the desired application (e.g., depending upon a shape ofthe retained portion of the medical article for which the retainer isdesigned to be used), the central channel 140 desirably has a sufficientlength in the longitudinal direction to stabilize the connector fitting,catheter hub, or other medical article, rather than act as a fulcrum forthe fitting, as mentioned above. That is, the retainer 120 receives asufficient length of the catheter hub to inhibit movement of the hub inthe lateral, longitudinal and transverse direction (i.e., to inhibityaw, pitch and axial movement of the article).

As shown most clearly in FIGS. 6 and 12, the lower side of the retainer120 includes an access or lower opening 150. In some embodiments, thelower opening 150 has generally tapering sides along the longitudinalaxis to match generally the shape of the medical article. In otherembodiments, the lower opening 150 has generally parallel sides whilethe channel 140 is tapered to match generally the shape of the medicalarticle. The lower opening 150 may include contouring (e.g., chamfers)along its periphery in order to guide the medical article into thecentral channel 140 when inserting the medical article into the retainer120.

The illustrated retainer 120 further comprises at least one retentionsurface 165(a), 165(b) disposed on a lower side of the inverted channel140. The retention surface holds at least a portion of the retainedmedical article within the channel 140 and hence away from the patient'sskin. This support can be provided by, for example, an adhesive, aregion of the inverted channel which provides a degree of snap-fit withthe retained medical article, two or more regions of the invertedchannel which provide a degree of snap-fit with the retained medicalarticle, or a combination of the adhesive and a region of snap-fit. Theadhesive can be located on one or more surfaces of the retainer 120 thatcontact the medical article. For example, the adhesive could be locatedon the surface of the inverted channel or on an abutment.

As shown most clearly in FIGS. 9 through 11, the present embodiment ofthe retainer 120 includes multiple pairs of retention surfaces 165(a),165(b). The corresponding retention surfaces 165(a), 165(b) of each pairlie on opposite sides of the access opening 150 from each other. In thisembodiment, the retention surface 165(a) is a portion of the surfacethat defines the central channel 140 and is located on the lower side ofthe central channel 140. The retention surface 165(a) is located to oneside of the central axis. The other retention surface 165(b) is aportion of the surface that defines the central channel 140 and islocated on the lower side of the central channel 140. The retentionsurface 165(b) is further located to the side of the central axis thatis opposite to the retention surface 165(a). Once the medical article isplaced in the central channel 140, the retention surfaces 165(a), 165(b)each hold a portion of the retained section of the article within thechannel 140. While multiple retention surfaces are illustrated in FIGS.9 through 11, either retention surface 165(a), (b) can be individuallyemployed in variations of the present retainer and still support themedical article within the channel 140.

As shown most clearly in FIG. 11, the retention surfaces 165(a), 165(b)are both located generally at a distance X measured in a transversedirection from the axis of the central channel 140. Distance Xpreferably is less than radius R when measured at the same locationalong the central channel 140.

Pressure can be provided by the retention surfaces 165 which holds themedical article within the retainer 120 in the illustrated embodiment.The retention surfaces 165 provide a degree of snap fit between theretainer 120 and the medical article. The degree of snap-fit can beincreased by extending the overall surface of the central channel 140through an arc of greater than 180°. As shown most clearly in FIG. 6, inone embodiment the arc extends for more than 180 degrees in order tomore firmly support the retained portion of the medical article. In theillustrated embodiment, the walls of the central channel 140 extendthrough an arc of approximately 270°. The length of such an arc providesa snap-fit securement between the central channel 140 on the body member130 and the secured portion of the medical article. In this way, themedical article can be placed in position prior to attaching thesecurement device 100 to the patient without concern that the medicalarticle will shift while the healthcare provider is attaching the device100 to the patient. Additionally, the releasable engagement provided bysnap-fit connection also permits the retained portion of the medicalarticle to be readily released from retainer 120.

In the illustrated embodiment, as best seen in FIG. 11, chamferedsurfaces 240(a) are formed on the underside of the retainer body 130along one of the lower edges of the access opening 150. A second set ofchamfered surfaces 240(b) are formed on the underside of the retainerbody 130 along the other lower edge of the access opening 150. Theportions of the retainer body 130 between these chamfered surfaces 240and the retention surfaces 165 form hips 270. In other words, the hips270 are the portion of the body 130 that is defined by a lower side ofthe central channel 140 (either the retention surfaces 165(a) on oneside of the central axis or the retention surfaces 165(b) on the otherside of the central axis), the chamfered surfaces 240, and the sides ofthe narrow lower opening 150. In one embodiment, the chamfered surfaces240(a) on one side of the central axis are oblique to the chambersurfaces 240(b) on the other side of the central axis and help guide themedical article into the lower opening 150 and the central channel 140.

The retainer 120 can include a generally rigid structure (at least incomparison to foam or tape) and is principally defined by the bodymember 130 and the mounting wings 210(a), 210(b). The body member 130,however, preferably is somewhat flexible in nature, due both in part toits structure and to the material used to form the body member 130.Suitably rigid but flexible materials include, for example, but withoutlimitation: plastics, polymers or composites such as polypropylene,polyethylene, polycarbonate, polyvinylchloride, acrylonitrile butadienestyrene, nylon, olefin, acrylic, polyester, as well as moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. However, other materials can be utilized.

The body member 130 and mounting wings 210(a), 210(b) are integrallyformed to comprise a unitary retainer. This can be accomplished in anyof a variety of ways well known to those skilled in the art. Forinstance, the entire retainer can be injection molded in order to reducefabrication costs. The illustrated retainer 120 preferably is formed byinjection molding using polyethylene or polypropylene material. Theretainer, however, can comprise a non-unitary body member 130 andmounting wings 210(a), 210(b). In this manner, the body member and oneor both of the mounting wings is formed separately and then coupledtogether. Additionally, the body member and mounting wings can haveother forms and can have other orientations relative to one another. Thebody member 130 also can be clear or transparent to facilitate alignmentof the retainer 120 with the catheter hub or other medical articleduring installation.

Each mounting wing 210(a), 210(b) preferably comprises a glue dam arounda portion of its periphery on its underside. The glue dam restrictsadhesive flow beyond an inner edge of the respective mounting wing. Theouter edge of each mounting wing 210(a), 210(b) does not include theglue dam (as best seen in FIG. 11) to allow any excess glue or adhesiveto seep out from under the mounting wing during the manufacturingprocess in the lateral direction away from the retainer 120.

The body member 130 of the retainer is attached to the upper surface 170of the anchor pad 110 via the mounting wings 210(a), 210(b), as is shownin FIG. 2. The body member is desirably secured to the upper surface ofthe pad by a solvent bond adhesive, such as cyanoacrylate or otherbonding material. One such adhesive is available commercially as PartNo. 4693 from the Minnesota Mining and Manufacturing Company (now 3M).

When the anchor pads 110 are secured to the skin of the patient, themedical article is inhibited from moving substantially in either thelateral or transverse directions relative to the patient. Longitudinalmovement of the medical article is inhibited by engagement between atleast one abutment surface on the retainer 120 and a contact surface ormating surface on the medical article. The abutment surface on theretainer 120 preferably extends generally normal to the axis of thecentral channel 140. The abutment surface can be located at or betweenthe distal and proximal ends of the retainer 120. For example, theabutment surface can be either the proximal or distal ends of theretainer (as will be apparent from the embodiments described later).Moreover, multiple abutment surfaces on the retainer 120 can be employedwith each abutment surface being the same or a different type ofabutment surface. Additionally, the abutment surface can be used toarrest movement in one longitudinal direction and the shape of thechannel can be used to arrest movement in the opposite longitudinaldirection. For example, at least a portion of the channel 140 can have atapering inner surface and the retainer can include an abutment surfacein the form of the proximal end of the retainer. The tapering shape andabutment surface cooperate to inhibit longitudinal motion in bothlongitudinal directions. In such an embodiment, the tapering surfacecontacts an outer tapering surface of the medical article to limitmotion in one direction. Likewise, the proximal end of the retainerabuts with a radially extending member on the medical article to limitmotion in the opposite direction.

The retainer 120 thus preferably includes one or more abutment surfaces.In the illustrated embodiment, the retainer includes multiple abutmentsurfaces that are formed by one or more slots 220 in the body member130. In the form of a slot 220, one abutment surface forms one side ofthe slot and another abutment surface forms the other side of the slot220.

To arrest longitudinal motion in the illustrated embodiment, two contactsurfaces in the form of a single radially extending member are employedon the medical article. The radially extending member extends throughthe slot 220 in the retainer 120 to inhibit longitudinal motion of themedical article in both directions. The contact between the two abutmentsurfaces on the retainer and their corresponding contact surfaces on themedical article arrests motion in the longitudinal direction. Furtherembodiments of the retainer 120 inhibit rotational movement of theinstalled medical article. This will be discussed in greater detailbelow.

As shown in FIG. 5, the retainer 120 includes pairs of abutment surfaceswith each pair forming one lateral slot 220 (preferably four abutmentsurfaces form at least two slots) that are sized to receive a radiallyextending portion of the catheter (e.g., a push tab that extends from acatheter hub). These slots 220 can extend circumferentially about atleast a portion of the axis of the central channel 140. Each slot has alongitudinal length sufficient to accept the radially extending memberof the retained medical article.

The radially extending portion of the medical article is preferably inthe form of a push tab. An embodiment of a push tab is described withreference to FIGS. 15A and 15B. In particular, it can be desirable forthe longitudinal length of each slot to be sufficient to receive thepush tab 310 of the medical article; however, each slot 220 can beslightly larger than the push tab's thickness (as measured in thelongitudinal direction) and a gap can exist between one or both sides ofthe push tab and the corresponding abutment surfaces that define theslot 220 into which the push tab has been inserted. In a preferred form,at least two or three annular slots 220 are disposed within the retainer120. The longitudinal length of each slot 220 preferably is about fivethousandths of an inch (0.005 inch, 0.127 mm) larger than the radiallyextending member (e.g., the push tab). Such an arrangement can bedesirable to minimize longitudinal movement of the retained portion(e.g., the tab 310 in FIG. 15B) of the medical article. Accordingly, asmall gap can exist between any abutment surface and a correspondingcontact surface before the medical article is shifted relative to theretainer 120. Once shifted, however, further longitudinal movement isprevented by the interference between the contact surface and theabutment surface.

Those of skill in the art will recognize that each slot 220 need nothave identical radial extent. The radial extent of each slot 220 neednot be uniform about the axis of the central channel 140.

The inner edges of each slot 220 can be chamfered so as to ease theinsertion of a radially extending member into any slot 220. By havingthe edges of each slot chamfered, it becomes possible to move a radiallyextending member 310 into a slot 220 even if the initial alignmentbetween the center of the slot and the center of the radially extendingmember is not exact. The use of chamfered edges on the slots 220, aswell as the presence of slots located at multiple longitudinal positionsalong the length of the central channel 140, allows for a medicalarticle to be placed into the central channel of the retainer 120 withonly coarse alignment with the axis of the central channel. The medicalarticle generally moves into the nearest slot 220 as the medical articleis pressed up into the retainer 120 from below (that is, as the retainer120 is pressed over the retained portion of the medical article). Thechamfered surfaces 240(a), 240(b) adjacent to the mounting wings 210(a),210(b) help guide the medical article into the central channel 140. Thealignment process is further facilitated when a portion of the retainer120 is transparent.

As shown most clearly in FIGS. 6, 11, and 13, an upper section of theretainer 120 further comprises a depression 135 which forms a finger padthat a healthcare provider can press down upon. The depression 135encourages the finger to push down on the retainer 120 and discouragesthe healthcare provided from gripping the retainer 120 on its sidesduring application. Such a side grip could squeeze or constrict theretainer 120 and make it harder to slip the retainer 120 over themedical article. By pushing down on the retainer 120, this constrictiveeffect is avoided.

As illustrated in FIGS. 6 and 13, a base surface 230 of the retainer 120can have a concave curved shape when viewed from the front and rearsides. The degree of curvature can be varied depending on the expectedlocation of usage or application of the securement device 100. It willbe appreciated that many common sites for insertion of medical lineswhich require securement will be located on anatomical regionsexhibiting convex curvature, such as a dorsal side of a hand, a arm, aleg, a contact surface, etc. By providing a concave bottom profile tothe retainer 120, the retainer will rock less once placed upon thepatient via the anchor pads 110(a), 110(b).

FIGS. 7 and 8 are side views of the retainer 120 of FIG. 5. Asillustrated in FIGS. 7 and 8, an axis 260 of the central channel 140lies at an angle with respect to the base surfaces 230 of the retainer120. The desired angle between the medical article and the patient iscreated by angling the axis 260 of the central channel 140. This angleis selected in order to align the axis 260 of the channel 140 of theretainer with the desired incident angle with which the medical articleis to contact the skin of the patient. A variety of different angles canbe used, ranging from 0° to 45°, and more preferably from 5° to 25°. Forinstance, for the securement of intravenous catheters, it is desirablefor the angle of incidence of the catheter to the skin of the patient tobe between about 7° to about 15°. For the securement of arterialcatheters, it is desirable for the angle of incident of the catheter tothe skin of the patient to be about 12.5°. By angling the axis 260 ofthe channel 140 at the desired angle, which will depend upon theparticular securement application (e.g., securing an arterial catheter,an intravenous catheter, etc.), the proper angle of incidence for acatheter can be maintained.

As illustrated in FIG. 5, the retainer 120 further comprises ribs 280.The ribs 280 project away from the outside surface of the channel 140.Such ribs may be formed by extending portions of the slots 220 of theretainer 120 away from the channel 140. The ribs 280 provide additionalsurfaces for the healthcare provider to grip the retainer 120.

As shown most clearly in FIGS. 5 and 7 through 10, located adjacent tothe slots 220 are upper sections 250. The thickness of the uppersections 250 in the longitudinal direction can vary in order to maintaina generally constant spring force along the entire length of theretainer 120. In this way, the same amount of force is required tospread the walls of the retainer 120 apart even though in theillustrated embodiment the back end of the retainer 120 spreads more toreceive the larger diameter section of a tapered catheter hub. Asillustrated in the cross-section views of FIGS. 9 and 10, thelongitudinal and transverse lengths of the upper sections 250 varybetween one or more of the upper sections.

Although certain features of the retainer 120 can be specificallyconfigured for use with a catheter hub, it will be understood by thoseof skill in the art that such a retainer 120 can be used with otheradaptors or medical lines as well. Furthermore, the retainers describedherein can be modified to more effectively cooperate with various typesof connector fittings and adaptors.

As shown in FIGS. 5 through 13, each slot 220 is substantially annularin form. However, as illustrated most clearly in FIG. 11, a stop memberor wall 290 preferably extends into the path of the one or more slots220 at a circumferential location about the axis of the central channel140. A comparison of FIGS. 9 and 10 illustrates that the wall 290 in theillustrated embodiment is located on the mounting wing 210(b) side ofthe retainer 120. As shown in FIG. 11, the wall 290 in the illustratedembodiment extends in a lateral direction away from the mounting wing210(b) and into one or more slots 220. In this way, the wall 290 limitsthe rotation of the radially extending member and medical article whenthe medical article is installed in the retainer 120. Thus, in theillustrated embodiment, one or more slots 220 extend circumferentiallyabout the axis of the central channel 140 for less than 360 degrees.

The wall 290 can be located at other locations around the circumferenceof the central channel 140. For example, the wall 290 could extend in alateral direction away from the mounting wing 210(a) and into one ormore slots 220. In embodiments of the retainer 120 where the wall 290extends into less than all of the slots 220, the healthcare provider canselect whether to restrict the rotation of the medical article. Forexample, the healthcare provider can restrict the rotation of themedical article by inserting a radially extending member of the medicalarticle into a slot 220 that includes the wall 290. Alternatively, thehealthcare provider can install the radially extending member into aslot 220 that does not include the wall 290 to allow unbridled rotationof the medical article. Moreover, more than one wall 290 can be locatedaround the circumference of the one or more slots 220 to further limitthe rotation of the medical article. In still further variations of theretainer, the retainer can omit the wall(s) 290.

Each slot 220 preferably has a lateral width sufficient to receive theradially extending member of the medical article. In this way, theretainer 120 is designed to grip non-winged catheters regardless of theposition of the radially extending member. For example, in theillustrated embodiment, a catheter hub can be installed into theretainer 120 regardless of rotation of the catheter hub about its axisexcept when the catheter hub is rotated such that the radially extendingmember coincides with the wall 290. The slot 220 can initially receivethe radially extending member whether the radially extending member ispointing away from the patient, toward the patient, to either side, orgenerally at any other angle about the axis of the catheter hub.However, when the radially extending member is pointing directly to theleft side and the catheter hub enters the opening 150, the radiallyextending member contacts the wall 290. As the catheter hub is furtherinstalled into the retainer 120, the catheter hub is forced to rotatesuch that the radially extending member is pointing downward. When theradially extending member is pointing downward, the radially extendingmember will follow the catheter hub into the retainer 120 as thecatheter hub is inserted through the opening 150. Once the catheter hubhas rotated and is subsequently fully installed in the retainer 120, thewall 290 will not allow the catheter hub and radially extending memberto rotate completely about the axis of the central channel 140. Forexample, as the catheter adapter is rotated, the radially extendingmember of the catheter hub slides within the slot 220. However, at somepoint during the rotation of the catheter hub, the radially extendingmember contacts the wall 290.

In the embodiment illustrated in FIGS. 5 through 13, the wall 290 limitsthe rotation of the radially extending member when the push tap issufficiently rotated in either direction towards the mounting wing210(b) side of the retainer 120. In this way, the wall 290 prohibits thecatheter hub from 360-degree rotation while the catheter hub isinstalled in the retainer 120.

When the radially extending member points downward (e.g., toward thepatient) and generally normal to the bottom surfaces of the retainer120, the radially extending member extends through the lower opening150. The hips 270 in the lower opening 150 are spaced sufficiently closeto capture the radially extending member in this position and therebyinhibit longitudinal movement of the catheter hub.

FIG. 12 is a bottom plan view of the retainer 120 and illustrates thatthe distance between the side mounting wings 210(a), 210(b) varies inthe region of the retainer 120. Width W1 is measured between the sidemounting wings 210(a), 210(b) in a lateral direction as shown. Width W2is measured between the side mounting wings 210(a), 210(b) in a lateraldirection as shown. FIG. 13 is a rear side view of the retainer 120 andfurther illustrates the widths W1 and W2 from FIG. 12. The side mountingwings 210(a), 210(b) are designed so that width W1 is less than thewidth W2. Width W1 is selected to deter backward insertion of themedical article into the retainer 120. For example, the width W1 couldbe selected to be smaller than a spin nut or the connector end of thecatheter hub. With W1 less than W2, the potential for the medicalarticle being incorrectly inserted into the retainer 120 is reduced.

Medical Articles

An exemplary medical article for use with the embodiment of thesecurement device described above will now be described with referenceto FIGS. 15A and 15B. The medical article can be a single medicalarticle or a combination of one or more medical articles. Such medicalarticles can be or include, for example, but without limitation,connector fittings, catheters, catheter hubs, catheter adaptors, fluidsupply lines, or other similar articles. FIG. 15A is a perspective viewof a catheter hub 430 and a connector fitting 300 with a spin nut 330.The connector fitting 300 is preferably disposed upon the end of amedical line 360 which can be connected to a drip bag, blood monitor, orother fluid related medical apparatus. While the retainer 120 of FIG. 2is configured to receive a portion of the catheter hub 430, the retainercan be configured for use with the connector fitting 300, as will bedescribed8.

The connector fitting 300 comprises an elongated body 320 which isattached to the end of the medical line 360. The connector fitting 300also comprises a portion that is tapered along at least part of itslongitudinal length so as to allow the end of this region to fit withinthe tapered conical portion of an catheter hub 430. The tapered portion350 of the connector fitting 300 also preferably includes a centrallydisposed lumen that communicates with the lumen of the medical line.

FIG. 15B is a perspective view of the connector fitting 300 of FIG. 15Awith the spin nut 330 secured in the proximal position and secured tothe catheter hub 430. When the connector fitting 300 is inserted intothe catheter hub 430, the lumen of the connector fitting is disposed influid communication with the lumen of the catheter hub 430. Thisprovides fluid communication between the medical line 360 and thepatient.

As seen in FIGS. 15A and 15B, the connector fitting 300 has at least twocontact surfaces in the form of one radially extending element 370(a)disposed upon an end of the elongated body 320 of the connector fitting300 opposite the tapered end 350. It may be advantageous for theradially extending element 370(a) to extend completely around thecircumference of the connector fitting 300. Additional contact surfacesin the form of a second radially extending element 370(b) can also bedisposed upon the elongated body 320, as can additional radial elements(not shown). Those of skill in the art will recognize that the radiallyextending element or elements 370(a) need not have any particular shapeor longitudinal thickness. Additionally, the radially extending elementsneed not have the same shape. For instance, the first radially extendingelement 370(a) can have the hexagonal shape illustrated and the secondradially extending element 370(b) can have a circular shape.

A spin nut 330 is disposed upon the connector fitting 300 around theelongated body 320 of the fitting. The spin nut 330 is substantiallycylindrical in form and is able to move upon the connector fitting 300.The spin nut 330 is capable of both rotational motion around the axis ofthe connector fitting and axial motion in both the proximal and distaldirections along the length of the elongated body 320 of the fitting.The spin nut 330 also includes internal screw threads which areillustrated with phantom lines in FIGS. 15A and 15B.

Still referring to FIGS. 15A and 15B, an catheter hub 430 includes abody that, in the illustrated embodiment, is configured as a catheterhub and has a generally conical shape and tapers from a large radius toa smaller radius along its length. In the illustrated embodiment, thecatheter hub 430 comprises two contact surfaces that together form aradially extending member. The radially extending member can be, forexample, a lateral tab 310 which is disposed at a position along thelength of the body of the hub. The tab 310 can be gripped by thehealthcare provider from the upper side of the retainer 120 in order toimmobilize the catheter hub 430 when unscrewing the spin nut 330 orotherwise disengaging the connector fitting 300 from the catheter hub.

The catheter hub 430 also can include an external screw thread on theoutside of the conical body near the end with the larger radius. Thescrew thread can be used in association with the spin nut 330 of theconnector fitting 300 in order to securely interconnect the connectorfitting 300 and the catheter hub 430.

The at least one retention surface 165 supports the medical article sothat the medical article is elevated in the retainer 120 such that theretained portion of the medical article (e.g., the retained portion ofthe catheter hub) is raised from the patient's skin to lessen oreliminate compression, excoriation, and/or chaffing of the skin. Thus,the retainer 120 lifts and holds the retained portion of the catheterhub up from the patient's skin.

With reference to FIG. 11, dimensions L1 and L2 illustrate how the wall290 described above prohibits 360-degree rotational movement of thecatheter hub 430 when the catheter hub 430 is installed in the retainer120. Referring to FIGS. 11 and 15, when the catheter hub 430 is fullyinstalled in the retainer 120, the push tap 310 extends in a directionaway from the central axis 340 of the catheter hub 430 and into the slot220. As shown in FIG. 15B, a maximum distance from the central axis 340to a distal end of the push tab 310 is distance T. With reference toFIG. 11, to allow the push tab of the catheter hub 430 to rotate in theregion of the mounting wing 210(a), a distance L1 is selected to beequal to or greater than the distance T. The distance L1 is measuredbetween the axis of the central channel 140 and the top surface of themounting wing 210(a) as shown in FIG. 11. Selecting L1 to be greaterthan the distance T permits the push tab 310 to rotate past the mountingwing 210(a).

In contrast, to limit rotation of the catheter hub 430 and push tab 310in the region of the mounting wing 210(b), a distance L2 is selected tobe less than the distance T. The distance L2 is measured between theaxis of the central channel 140 and the top surface of the wall 290 asshown in FIG. 11. Selecting L2 to be equal to or preferably less thanthe distance T does not permit the push tab 310 to rotate past themounting wing 210(b).

An advantage of limiting the rotation of the catheter adapter 430 whenit is installed in the retainer 120 can be understood with referenceback to FIG. 15B. In FIG. 15B, the connector fitting comprises anelongated body 320 which is attached to the end of a medical line. Theother end of the elongated body 320 connects to the catheter adapter orhub 430. The push tab 310 is disposed at a position along the length ofthe body of the hub. A spin nut 330 is disposed around the elongatedbody 320 of the fitting. Internal screw leads within the spin nut 330engage with an external screw thread on the catheter hub 430 in order tosecurely interconnect the connector fitting and the catheter hub 430.

With reference to FIGS. 5 through 13, since the push tab 310 willcontact the wall 290 of the retainer 120 when the spin nut is rotatedless than 360 degrees, once the push tab 310 contacts the wall 290, thehealthcare provider can connect or disconnect the elongated body fromthe catheter adapter 430 without having to also grip the tab 310. Oncethe healthcare provider rotates the fitting in either direction so thatthe tab 310 contacts the wall 290, the catheter hub 430 is effectivelyimmobilized in that direction such that further rotation of the catheterhub 430 in that direction is prohibited. Once immobilized, thehealthcare provider can unscrew the spin nut 330 or otherwise disengagethe connector fitting from the catheter hub with a single hand. Whilethe use of two hands may be advantageous in certain circumstances whenoperating the spin nut 330, the retainer 120 allows the healthcareprovider to use a single hand.

Similarly, when connecting or re-connecting the elongated body to thecatheter hub, the healthcare provider can initially rotate the push tab,via the spin nut, until the push tab contacts the wall 290. Once thepush tab contacts the wall 290, the catheter hub is immobilized whichcan enhance further connecting of the elongated body to the catheterhub. In this way, the healthcare provider can continue to turn the spinnut until the spin nut is fully engaged with the catheter hub withouthaving to grip the push tab or catheter hub.

The retainer 120 can be used with both luer slip and luer lock connectorfittings. The retainer 120 is designed such that even with the push tab310 positioned in the forward most slot 220, the retainer can fit in thespace defined between the push tab 310 and the spin nut 330 with thespin nut fully engaged. The retainer 120 can be further sized to closelyfit within this space to provide redundancy in arresting longitudinalmovement of the catheter hub 430 relative to the retainer 120. Suchslots 220 can also be disposed to extend longitudinally to accommodateradially extending members of greater longitudinal length, such as thesplines of a Kipp-style connector.

Operation

An exemplary process for coupling a medical article with the securementdevice described above will now be described with reference to FIGS. 16through 18.

A preferred method of using the preferred embodiment of the securementdevice illustrated in FIGS. 1-13 will be described in the context ofstarting an intravenous line. However, the aspects and features of theoperational method and the use of the present securement device is notlimited to this particular application.

A heathcare provider preferably begins the procedure by inserting an IVcatheter into patient's vein in a known manner and then attaching anintravenous line to the IV catheter though the luer connection. Inparticular, the healthcare provider inserts the tapered or luer end 350of the connector fitting 300 into the catheter hub 430 and then turnsthe spin nut 330 to thread the spin nut 330 over a thread flangedisposed at the distal end of the catheter hub 430. This action drawstogether the two medical article components and releasably interlocksthem. The immediate connection of the IV line to the catheter inhibits aback flow of blood through the catheter. The healthcare provider nowpreferably secures the IV catheter in place on the patient using thesecurement device 100. In some variations of this method, however, thesecurement device 100 can be first be attached to one or both of themedical article (as well as the possibly to the patient) before thehealthcare provider makes the connection between the two medicalarticles.

In order to illustrate more clearly the interaction between the retainer120 and the catheter hub 430 in this embodiment, the anchor pads 110(a),110(b) of the securement device 110 are illustrated as detached from theretainer 120. In accordance with the preferred embodiment, however, theentire securement device 100 is assembled in accordance with theabove-description (e.g., the mounting wings 210 are attached to theanchor pads) and is sterilized before use.

FIG. 16 is a perspective view of the connector fitting 300 secured tothe catheter hub 430, both aligned with the anchor pad 110(a), 110(b)and the retainer 120. Healthcare provider can secure a medical line 360and the medical articles to a patient using the above-describedsecurement device 100 or a readily apparent modification thereof. Thehealthcare provider aligns the central channel 140 of the retainer 120over the adaptor or catheter hub 430.

FIG. 17 is a perspective view of the connector fitting 300 secured tothe catheter hub 430 with the catheter hub being inserted into theretainer 120. The lower opening 150 in the retainer 120 is pressed overthe catheter hub 430 whereby the catheter hub fitting slides into thecentral channel 140 of the body member 130. Depending on the diameter ofthe catheter hub 430, the retention surface 165 can provide a snap-fitconnection between the hub and the body member 130. The contact surfacesof the catheter hub preferably form one or more radially extendingmembers 310 (e.g., one or more push tabs or annular collars), as shownin the illustrated embodiment. The radially extending member(s) fitsinto one (or more) of the lateral slots 220 in the retainer. As can beseen, the tab 310 of the catheter hub 430 lies within one of the slots220 of the retainer 120. In addition, the body of the catheter hub 430generally lies within the central channel 140 of the retainer. Whenguided through the lower opening 150 by the healthcare provider, thebody of the catheter hub 430 will lie within the central channel 140 ofthe retainer 120. The abutment surfaces of the slot 220 will inhibitlongitudinal migration of the catheter hub 430 through the centralchannel 140 of the retainer 120.

In addition, if used with a connector fitting 300 in which a portion ofthe connector fitting, such as the spin nut 330, has a greater radialsize than the size of the central channel 140 of the retainer 120, thespin nut 330 can act as a contact surface and will inhibit axial motionin one direction through the central channel 140 of the retainer aswell. Using the size of the spin nut 330 or other element having greaterradial size than the size of the channel is not required for effectiveoperation of the systems described herein; however, such a technique maybe an effective form of securement or redundant securement in someapplications.

The combination of the channel shape 140 (both the truncated circularshape and the tapering width), the top of the retainer, and theinterengagement between the slot(s) 220 and the radially extendingmember(s) 310 on the catheter hub 430 arrest movement of the retainedsection of the medical line in three dimension: longitudinally,laterally and transversely. Further, the wall 290 in the illustratedembodiment prohibits the catheter hub from 360-degree rotation while thecatheter hub is installed in the retainer 120. The rotational stopprovided by the wall 290 allows the heathcare provider to attach anddetach the spin nut (and thus the connector fitting) to and front thecatheter hub without having the remove the catheter hub from theretainer. While this feature is preferred in the illustratedapplication, it is optional and the wall 290 can be omitted from thesecurement device, as noted above.

FIG. 18 is a perspective view of the retainer 120 attached to the anchorpads 110 and securing the catheter hub 430 therein. Once the catheterhub or other medical article enters the lower opening 150 of theretainer 120, the anchor pads 110(a), 110(b) are secured to the patient.The central channel 140 of the retainer surrounds an arc length of morethan 180 degrees of the medical article. This inhibits any transverse orlateral motion of the medical article relative to the retainer 120. Thecatheter hub can be inserted into the retainer either before or afterthe fitting connector is attached to the hub.

The healthcare provider can first remove one portion of the releaseliner 180 from the anchor pad 110 by gripping the pull tab 190 andpulling the liner 180 away from the lower surface 160 of the anchor pad110. This exposes the adhesive layer of the anchor pad, which can thenbe applied to the skin of the patient near the site where the healthcareprovider desires to secure the connector fitting 300 or other medicalarticle. The adhesive layer of the second anchor pad which is located ina lateral direction from the first anchor pad can be similarly exposed.The remainder of the release liner 180 for the first and second anchorpads can then be removed and the anchor pad fully attached to the skinof the patient. As a variation, the release liner on one anchor pad canbe pulled away and the anchor pad can be fully attached to the patientbefore attaching the second anchor pad to the patient.

Additional Embodiments

As understood from the above description of the securement deviceembodiment shown in FIGS. 1-13 and 16-18, the securement device 100arrests longitudinal movement of the retained section of the catheterhub 430 by interacting with at least one and preferably two contactsurfaces of the tab 310, which constitutes a radially extending memberin the illustrated embodiment. This approach for arresting longitudinalmovement can also be used with other types of radially extending membersor contacts (e.g., contact surfaces) on the catheter hub 430, theconnector fitting 300 or other medical articles or components thereof.For example, a retainer can be configured to capture or receive a tab,spline (e.g., a longitudinally extending spline) or collar on theconnector fitting that is disposed on the distal side of the spin nut320, or can capture all or a portion of the spin nut. In otherembodiments, the retainer can be configured to fit between contacts on amedical article or medical articles. For example, the retainer can besized to fit between the spin nut 320 and the hexagonal collar 370 onthe connector fitting 300 or between the proximal side of the spin nut320 and the distal side of the catheter hub tab 310. In such cases, theend surfaces of the retainer function as the abutment surfaces andcooperate with adjacent contacts on the medical article(s).Additionally, the retainer can be configured to not only fit between twocontacts on the medical article(s) but also can be configured to receiveone or more radially extending members of the medical article(s).

In a variation of this approach, longitudinal movement can also be fullyarrested (i.e., arrested in both directions along the longitudinal axis)by (1) the interaction of an abutment on the retainer and a distallyfacing contact in combination with (2) the shape of the channel 140. Forexample, in the previously discussed embodiment, the tapering shape ofthe channel 140, which decreased in size in the proximal direction,inhibited longitudinal movement toward the insertion site. Theinteraction between a proximal side wall of the slot 220 and the distalside of the catheter hub tab 310 prevents longitudinal movement in thedistal direction. Thus, some embodiments need only include one abutment.As noted above, the channel can have a tapering shape along at least aportion of its length and a step down in diameter along its length (asbest illustrated in FIG. 14B). The tapering shape can arrestlongitudinal movement in one direction and an abutment, which is formedat the diameter step down, can interact with a corresponding contact(e.g., contact surface) on the medical article to arrest longitudinalmovement in the opposite direction.

Several variations of the retainer design are described below inconnection with FIGS. 19-28. These retainer designs cooperate withcontact points or surfaces on the connector fitting 300 to arrestmovement in the longitudinal direction. Depending on what contact pointsor surfaces are provided on the connector fitting 300, (for example,radially extending members, spin nuts, collars, tabs), one or moreabutments on the retainer will generally abut against one or more of thecontact points or surfaces (as noted above a slight gap can occur insome applications). Additional or redundant abutment points or surfacesmay be provided.

One embodiment (FIG. 19) illustrates a retainer 120 designed to fitbetween the spin nut 330 and a hexagonal collar 370 a on the connectorfitting (FIGS. 20 and 21) as shown in FIG. 22. In this embodiment, thedistal and proximal ends of the retainer 120 are the abutment surfaces.

Additionally, the body member 1300 in this embodiment may or may notinclude a groove, slot or other receptacle in the channel 140 forreceiving a ring 1400 or connector tab 310 (FIGS. 20 and 21). Moreover,depending on the radial extent of the ring 1400 or connector tab 310,such a groove, slot, or receptacle may or may not extend through thewall of body member 1300. The retainer previously described withreference to FIGS. 1-13 incorporates such a groove, slot, or receptaclein the form of a slot 220 for engaging with the catheter hub 430 (seeFIG. 18). This slot 220 extends through the wall of the retainer. Toillustrate how a groove, slot, or receptacle in the body member 1300(FIG. 19) would engage with a radially extending member on the connector300, one of the slots 220 in the retainer from FIGS. 1-13 is shown inFIG. 26 as being aligned with a hexagonal nut 1400 on the connector body320. Once installed, the hexagonal nut 1400 can abut against theproximal and distal abutment surfaces of the slot 220. By providing agroove in the channel 140 of the body member 1300, motion of theretainer can be further inhibited by the interaction of the groove withthe ring or tab. Even if a groove(s) is not provided in the retainerillustrated in FIG. 22 and the channel 140 does not fit flush againstthe connector body 320, partial contact between the abutment surfacesand the spin nut 330 and hexagonal collar 370 a can inhibit longitudinalmotion.

In contrast to the connector fitting embodiments illustrated in FIGS. 20and 21, the connector fitting illustrated in FIG. 15B does not include aradially extending member that is located between the ends of theconnector fitting 300. The channel 140 of the retainer embodied in FIG.19 forms an improved fit with the connector fitting illustrated in FIG.15B as shown in FIG. 23. In FIG. 23, the retainer can generally abutagainst the spin nut and the hexagonal collar 370 a to inhibitlongitudinal movement.

Another embodiment illustrates the retainer 120 being pressed overradially extending members 370 a, 370 b (FIG. 24). Unlike theembodiments described with reference to FIGS. 22 and 23, the length ofthe retainer in FIG. 24 is not selected to fit between distal andproximal contact surfaces on the connector fitting. Instead, the bodymember 1300 in this embodiment includes one or more grooves, slots orother receptacles in the channel 140 for receiving the radiallyextending members 370 a, 370 b. The grooves or slots form abutmentsurfaces that abut against contact surfaces on the radially extendingmembers 370 a, 370 b to inhibit longitudinal motion of the medicalarticle.

Another embodiment illustrates a retainer 120 designed to fit betweenthe spin nut 330 and the hexagonal nut 1400 on the connector fitting(FIG. 20) as shown in FIG. 25. Unlike the embodiment illustrated in FIG.22 where a groove or slot in the channel 140 provides a flush fitbetween the connector body 320 and the retainer, the retainer in FIG. 25forms a flush fit without a groove or slot. Instead, the shorter lengthof the retainer in FIG. 25 allows the retainer to fit between twoadjacent contact points or surfaces. For example, the retainerillustrated in FIG. 25 fits between the spin nut 330 and the hexagonalnut 1400.

An additional embodiment of a retainer is illustrated in FIGS. 27A-J and28. Only the central channel 1500 of this embodiment differs from theabove-described embodiment in that the central channel preferably has agenerally constant cross-sectional shape (e.g., a generally constantdiameter to cooperate with a tubular connector fitting body). Incontrast to the retainer designs describe with reference to FIGS. 22 and26, the constant cross-sectional shape of the retainer design describedwith reference to FIGS. 27A-J can form an improved fit with the constantdiameter of the connector body 320.

A retainer in accordance with another embodiment of the invention isillustrated in FIG. 19, with FIG. 19 showing a perspective view of aretainer and anchor pads that are similar to FIG. 1 above. Only the bodymember 1300 of this embodiment differs from the above-describedembodiment. Accordingly, the above description applies equally to theembodiment of FIG. 19, unless otherwise indicated.

The body member 1300 of the retainer 120 illustrated in FIG. 19preferably is configured to retain a portion of a medical article thathas a generally constant outer radius along its length. (In contrast,the embodiment of the retainer described with reference to FIGS. 1 and16 was sized to retain a tapering portion of the medical article.) Inthe embodiment described with reference to FIG. 19, the inner surface ofthe inverted central channel 140 is sized to match or approximatelymatch the outer radius of the medical article. To arrest longitudinalmotion of the medical article, one or more abutment surfaces on the bodymember 1300 with one or more contacts on the medical article.

The inner surface of the central channel 140 in the illustratedembodiment has a generally semi-circular cross-sectional shape. Theinner surface contour of the central channel 140 is selected dependingon the diameter or geometry of the portion of the medical article to beretained. For example, since the retainer 120 in FIG. 19 is configuredto retain a portion of a connector fitting that has a constant outerdiameter (see, e.g., the connector fitting illustrated in FIG. 15A), thecentral channel can have a constant radius along its length. By matchingthe inner surface contour of the central channel 140 to the outersurface of the secured portion of the medical article, a more effectivesecurement may be achieved.

Other embodiments of the retainer 120 can have an inner surface that isconfigured to match, or closely match, an outer surface of a raisedportion of the connector fitting. Such a raised portion of the connectorfitting can be in the form of two contact surfaces which together form aradially extending member, e.g., an annular collar, ring, or hex nut. Byselecting an inside surface contour for the retainer that matches orclosely matches the annular member, a form of snap-fit can be achievedbetween the retainer and the connector fitting when the connectorfitting is engaged with the retainer.

The annular member and the connector fitting can be manufacturedindividually or as a unitary member. If the inside surface contour ofthe retainer 120 is substantially larger than the outer diameter of theconnector fitting, an annular member can be installed around theconnector fitting to allow a form of snap-fit between the outer diameterof the annular member and the inside surface of the retainer. In such anembodiment, the annular member alone may not inhibit longitudinal motionof the medical article. However, advantageously, the same retainer canbe used with connector fittings with different outer diameters.Moreover, a connector fitting can include more than one annular member.Each annular member can have a different outer diameter whereby theconnector fitting can be used with retainers 120 that have differentinner surface diameters or the same diameter sufficiently sized toreceive the irregularly shaped connector fitting. Additionally, in someforms of the retainer, abutments in the form of, for example, abutmentsurfaces that define, at least in part, a groove are employed to abutagainst one or both of the contact surfaces of the annular member. Byengaging the groove with at least a portion of the annular member,longitudinal motion of the connector fitting relative to the retainercan be inhibited, as described below.

In addition or in the alternative, effective longitudinal securementbetween the retainer and the connector fitting can also be achieved bythe engagement of the radially extending member or annular memberbetween the retainer and the medical article. The radially extendingmember can be in the form of, for example, an annular collar aspreviously described. For example, a tab similar to the push tab on thecatheter hub of FIG. 15A could be located on the outer surface of theconnector fitting. The push tab could engage an abutment surface(s) inthe form of a recess or receptacle on the inner surface of the retainer120. The recess or receptacle in the retainer 120 can be in the form of,for example, a slot or groove. By engaging the push tab within therecess, longitudinal movement of the connector fitting with respect tothe retainer is further limited. Exemplary radially extending memberswhich can form a snap-fit with the inner surface of the retainer and/orengage a recess or groove in the retainer are described below withreference to FIGS. 21 and 22.

In addition or in the alternative, the longitudinal length of theretainer 120 can be selected to match, or closely match, thelongitudinal distance between a first contact surface and a secondcontact surface of the connector fitting 320. The first and secondcontact surfaces can be in the form of first and second radiallyextending members that extend from the medical article. For example, thesecond radially extending member could be a spin nut of a catheter hub.For ease of discussion, the longitudinal length of the retainer 120 isillustrated in FIG. 19 as dimension A.

Connector fittings for use with the embodiment of the retainerillustrated in FIG. 19 are illustrated in FIGS. 20 and 21, with FIG. 20showing a connector fitting and a catheter hub with a ring secured tothe connector fitting, and FIG. 21 illustrating another connectorfitting secured to a catheter hub with a radially extending tab securedto the connector fitting are similar to FIG. 15B above. Only theconnector fitting of these embodiments differs from the above-describedembodiment. Accordingly, the above description applies equally to theembodiments of FIG. 20-21, unless otherwise indicated.

FIG. 20 is a perspective view of a connector fitting secured to acatheter hub 430, with the connector fitting having two contact surfacesforming a ring 1400. The ring 1400 increases the diameter of theconnector fitting to more closely match the inner surface of theretainer. By increasing the diameter of the connector fitting, the ring1400 and the retainer can form a snap-fit. To arrest longitudinalmovement of the medical article, the connector fitting can includecontact surfaces in the form of a radially extending member 370 a andspun nut 330. The ring 1400 is located between the radially extendingmember 370 a and the spin nut 330. The contact surface on the proximalside of the radially extending member 370 a can abut against an abutmentsurface in the form of a distal end of the retainer. Additionally, thecontact surface on the distal side of the spin nut 330 can abut againstan abutment surface in the form of a proximal end of the retainer. Whenthe connector fitting is inserted into the adapter 430, the lumen of theconnector fitting is disposed in fluid communication with the lumen ofthe adapter 430. This provides fluid communication between the medicalline 360 and the patient.

The ring 1400 is illustrated as a hex nut located around thecircumference of the elongated body 320 of the connector fitting 300.Alternatively, the ring 1400 can have a circular outer surface similarto the illustrated outside diameter of the spin nut 330. A non-circularshape may be preferred to further inhibit rotational movement of theretainer 120 around the longitudinal axis when the retainer is installedover the connector fitting. The ring 1400 need not have the same shapeas the first or second radially extending members 370 a, 370 b. Forinstance, the ring 1400 can have a circular shape and the first andsecond radially extending members 370 a, 370 b can have the hexagonalshape illustrated.

The ring 1400 can be fixed to the elongated body 320 or allowed to slidein a longitudinal direction along the elongated body 320. Those of skillin the art will recognize that the ring 1400 need not have anyparticular shape or longitudinal thickness. In some applications, asdescribed below in connection with FIG. 22, it may be preferable toincrease the longitudinal length of the ring 1400 (i.e., make the ringthicker) to inhibit the ring from acting as a fulcrum when the connectorfitting is inserted into the retainer illustrated in FIG. 22.

Alternatively, or in addition to the abutment surfaces described above,including one or more abutment surfaces in the inner surface of theretainer 120 can further inhibit longitudinal movement. Depending on theradial dimension of the ring 1400, the abutment surface(s) can extendinto or through the wall of the retainer to form a groove or slot,respectively. The groove or slot receives at least a portion of the ring1400. The groove or slot can be sized to either receive the ring in aloose or close-fit manner. With the addition of a groove, longitudinalmovement of the connector fitting 300 relative to the retainer 120 canstill be inhibited by the interaction between the ring 1400 and thegroove within the central channel 140, especially if the ring 1400 fitsclosely into the groove.

Additionally or in the alternative to the one or more abutment surfacesor to the snap-fit engagement, at least a portion of the central channel140 in all of the illustrated embodiments can be at least partiallycoated with an adhesive (e.g., an adhesive that preferably releasablyholds the fitting within the retainer channel) to limit or restrictlongitudinal movement. Alternatively, the medical article can include anadhesive section to hold the medical article in the channel and/orrelative to the retainer.

The central channel 140 described with reference to FIG. 19 isconfigured to retain the outer surface of the ring 1400. In this way,the retainer 120 can snap-fit over the ring 1400, thereby retaining themedical article within the retainer. The central channel 140 can have ahexagonal or other non-circular shape to further inhibit rotationalmovement of the connector fitting with respect to the retainer 120.

As illustrated in FIG. 20, the longitudinal length between the spin nut330 and the first radially extending member 370 a is dimension B. Withreference to FIGS. 19 and 20, the longitudinal length of the retainer120, dimension A, can be selected to allow the retainer 120 to fitsnugly between and preferably abut the contact surfaces of the firstradially extending member 370 a and the spin nut 330. As noted above, aslight gap can exist between the abutment and contact surfaces; however,a tighter fit will lessen any relative longitudinal movement between theretainer and the connector fitting. In this way, the connector fitting300 will be inhibited from moving in a longitudinal direction relativeto the retainer 120 once the connector fitting 300 is secured within theretainer.

Alternatively, the longitudinal length of the retainer 120, dimension A,is selected to be less than the distance between the first radiallyextending member 370 a and the spin nut 330, dimension B. With dimensionA less than dimension B, the ease by which the connector fitting isinstalled into the retainer 120 may be increased.

FIG. 21 is a perspective view of a connector fitting 300 secured to acatheter hub 430, with the connector fitting having two contact surfacesforming a tab 310. As briefly described with reference to FIG. 20, thetab 310 or ring 1400 can cooperate with a groove or slot 220 in theretainer to limit longitudinal movement of the medical article wheninstalled in the retainer. In particular, it can be desirable for thelongitudinal length of each slot 220 to be sufficient to receive the tab310 of the medical article. The slot 220 receives the tab 310 from theretained portion of the medical article.

Combinations of the retainer 1300 with the connector fittingsillustrated in FIGS. 15, 20, and 21 are illustrated in FIGS. 22-25. FIG.22 is an exploded, perspective view of the connector fitting 300 and thecatheter hub 430 of FIG. 20 with the ring 1400 of the connector fittingbeing aligned with the anchor pad and the retainer of FIG. 19. Theinverted channel 140 in the retainer 120 is pressed over the connectorfitting 300 whereby the connector fitting slides into the centralchannel of the body member 1300. The body member 1300 in this embodimentdoes not include grooves, slots or other receptacles for receiving thering 1400. Rather, depending on the outer diameter of the ring 1400, asnap-fit between the ring 1400 and the inner surface of the body member1300 can be formed. In addition, the longitudinal length of the ring1400 (i.e., its thickness) can be selected to inhibit the ring fromacting as a fulcrum point for the retainer 120. Alternatively, or inaddition to, the longitudinal length of the body member 1300, dimensionA, can be selected to fit between the first radially extending member370 a and the spin nut 330, dimension B. As previously described, thespin nut 330 and/or the first radially extending member 370 a can arrestaxial movement in one or two directions of the connector fitting 300when installed in the retainer 120.

FIG. 23 is an exploded, perspective view of the connector fitting 300and catheter hub 430 of FIG. 15B with the elongated body 320 of theconnector fitting 300 being aligned with the anchor pad and the retainerof FIG. 19. The inverted channel 140 in the retainer 120 is pressed overthe connector fitting 300 whereby the connector fitting slides into thecentral channel of the body member 1300. In the embodiment describedwith reference to FIG. 23, the channel 140 receives the elongated body320 of the connector fitting 300 and is generally configured to house,to preferably grip, and to secure the elongated body 320. The elongatedbody may have a constant outer diameter. In the embodiment illustratedin FIG. 23, the channel 140 is configured to retain an elongated body320 which has a constant outer diameter.

Alternatively the elongated body may incorporate one or more contactsurfaces in the form of a varying outer diameter or a tapering outersurface. To engage with the tapering outer surface, the channel 140 caninclude one or more abutment surfaces in form of a matching taperinginner surface along its length. Additional embodiments of the centralchannel 140 of the retainer can comprise a plurality of differentabutment surfaces in the form of radii and/or tapering regions. In thisway, the size (i.e., radii, tapered) of the central channel 140 can bechosen to match or approximate the size of various standard connectorfittings, catheter hubs or possibly all or portions of both. By matchingthe inner surface contour of the central channel 140 to the outersurface of the connector fitting, a more effective securement may beachieved.

In addition, if the longitudinal length of the retainer 120, shown asdimension A, is selected so that the retainer closely fits between thefirst radially extending member 370 a and the spin nut 330, dimension B;the spin nut and the radially extending member will further inhibitaxial motion in one or more directions through the central channel 140of the retainer. Alternatively, if the longitudinal length of theretainer 120 is selected to be less than dimension B, the spin nut orthe radially extending member will inhibit axial motion in one directionthrough the central channel 140. Additionally, the central channel caninclude an adhesive coating that covers at least a portion of thechannel to hold the elongated body of the connector fitting relative tothe retainer.

FIG. 24 is an exploded, perspective view of the connector fitting 300and catheter hub 430 of FIG. 15B with the radially extending elements370 a, 370 b of the connector fitting being aligned with an anchor padand a body member 1300 of the retainer 120. The anchor pad and theretainer 120 of this embodiment are configured similar to the anchor padand the retainer illustrated in FIG. 19; however, the size of thecentral channel differs in each embodiment. In the embodimentillustrated in FIG. 23, the lower channel in the retainer 120 is pressedover the radially extending members 370 a, 370 b whereby the connectorfitting 300 slides into the central channel of the body member 1300. Incontrast to the method of securing the connector fitting 300 to theretainer 120 in FIG. 23, the radially extending members 370 a, 370 bshown in FIG. 24 fit within the central channel 140 of the body member1300. The connector fitting 300 preferably includes one or more contactsurfaces in the form of radially extending members 370 a, 370 b as shownin the illustrated embodiment. The radially extending members 370 a, 370b can provide a snap-fit between the connector fitting 300 and the bodymember 1300. That is, the size and shape of the channel closely matchesthat of the radially extending members 370 a, 370 b. However, theengagement between the connector fitting and the retainer 120 may notarrest longitudinal movement of the medical article.

Additionally, one or more abutment surfaces in the inner surface of theretainer 120 can further inhibit longitudinal movement. Depending on theradial dimensions of the radially extending members 370 a, 370 b, theabutment surface(s) can extend into or through the wall of the retainerto form a groove or slot, respectively. The groove or slot receives atleast a portion of the radially extending members 370 a, 370 b. Thegroove or slot can be sized to either receive the radially extendingmembers 370 a, 370 b in a loose or close-fit manner. With the additionof a groove, longitudinal movement of the connector fitting 300 relativeto the retainer 120 can still be inhibited by the interaction betweenthe radially extending members 370 a, 370 b and the groove within thecentral channel 140, especially if the radially extending members 370 a,370 b fits closely into the groove.

Additionally or in the alternative, at least a portion of the centralchannel 140 can be coated with an adhesive (e.g., an adhesive thatreleasably holds the fitting within the retainer channel).

FIG. 25 is an exploded, perspective view of the connector fitting 300and the catheter hub 430 of FIG. 20 with a portion of the elongated bodyof the connector fitting being aligned with the anchor pad and theretainer of FIG. 19. The central channel 140 in the retainer 120 ispressed over the connector fitting whereby the connector fitting slidesbetween the anchor pads 110(a), 110(b) and into the central channel 140of the body member 1300. As illustrated in FIG. 25, the longitudinallength of the body member 1300, denoted as dimension C, is selected tofit between the spin nut 330 and the ring 1400, dimension D. Thelongitudinal length of the body member 1300 can be selected to closelyfit between the contact surface of the ring 1400 and the contact surfaceof the spin nut 330. In such a configuration, axial movement of theconnector fitting 300 with respect to the retainer 120 can be inhibitedby engagement between the abutment surfaces of the retainer and thecontact surfaces of the connector fitting. Alternatively, the dimensionC is selected to fit between the first radially extending member 370 aand the ring 1400.

Additional embodiments of the central channel 140 of the retainer cancomprise a plurality of different abutment surfaces in the form of radiiand/or tapering regions. In this way, the size (i.e., radii, tapered) ofthe central channel 140 can be chosen to match or approximate the sizeof various standard connector fittings. By matching the inner surfacecontour of the central channel 140 to the outer surface of the connectorfitting, a more effective securement may be achieved.

FIG. 26 is an exploded, perspective view of the connector fitting 300and catheter hub 430 of FIG. 20 with the connector fitting being alignedwith the anchor pad and the retainer of FIG. 1. As shown, the connectorfitting 300 includes two contact surfaces in the form of a ring 1400which fits between two of the abutment surfaces that form one of thelateral slots 220 in the retainer. In this way, the ring 1400 will fitwithin one of the slots 220, thereby arresting longitudinal movement ofthe connector fitting 300 when installed in the retainer 120. The slots220 have a longitudinal length sufficient to accept the ring 1400 of theretained medical article.

The inverted central channel 140 in the retainer 120 is pressed over theconnector fitting 300 whereby the connector fitting slides between theanchor pads 110(a), 110(b) and into the central channel of the bodymember 130. When guided through the lower opening 150 by the healthcareprovider, the elongated body of the connector fitting 300 will liewithin the central channel 140 of the retainer 120. Depending on thediameter of the ring 1400 and the outer diameter of the connectorfitting, a snap-fit between the ring and the body member 130 can beformed. The abutment surfaces forming the slots 220 will inhibitlongitudinal migration of the connector fitting 300 through the centralchannel 140 of the retainer 120.

In addition, if the longitudinal length of the retainer 120, shown asdimension A, is selected so that the retainer can fit between thecontact surface of the first radially extending member 370 a and thecontact surface of the spin nut 330, dimension B, the spin nut and theradially extending member will further inhibit axial motion in one ormore directions through the central channel 140 of the retainer.Alternatively, if the longitudinal length of the retainer 120 isselected to be less than dimension B, the spin nut or the radiallyextending member will inhibit axial motion in one direction through thecentral channel 140. Such a technique may be an effective form ofadditional securement in some applications.

The combination of the channel shape (constant radius), the enteringengagement between the abutment surfaces and the ring 1400 on theconnector fitting, and the longitudinal length of the body member 130 ofthe retainer 120 arrest movement of the retained section of the medicalarticle in three dimensions: longitudinally, laterally, andtransversely. Further, the wall 290 prohibits the connector fitting from360-degree rotation while the connector fitting is installed in theretainer.

A retainer in accordance with another embodiment of the invention isillustrated in FIGS. 27A through 27J that are similar to the retainerdescribed in FIGS. 1-13 and 26 above. Only the central channel 1500 ofthis embodiment differs from the above-described embodiment in that thecentral channel preferably has a generally constant cross-sectionalshape (e.g., a generally constant diameter to cooperate with a tubularconnector fitting body). Accordingly, the above description appliesequally to the embodiment of FIGS. 27A through 27J, unless otherwiseindicated.

The retainer 120 illustrated in FIGS. 27A-27J includes a body 130 thatdefines a central channel 1500 and a pair of mounting feet 210 a, 210 bdisposed on opposite sides of the body 130. The opening into the centralchannel 1500 is chamfered to ease insertion of the fitting connectorinto the retainer 120. The bottoms of the mounting feet 210 a, 210 bgenerally define a plane and a central axis of the central channel 1500that is skewed relative to the plane, as best seen in FIGS. 27F and 27I.

The body 130 preferably defines at least two abutment surfaces to formone slot 220 and more preferably defines additional abutment surfaces toform additional slots 220. The slots 220 are sized to one or morecontact surfaces on the connector fitting. For example, as illustratedin the present embodiment shown in FIGS. 27J and 28, each slot canreceive contact surfaces in the form of the hex nut rings 370 a, 370 b,1400, and/or connector tabs 310 that are included on the variousconnector fittings illustrated in FIGS. 15A, 15B, 20, and 21.

The longitudinal length of the body 130 preferably is sized so thatabutment surfaces located at the proximal and distal ends of theretainer fit closely between the distal contact surface of the spin nut330 and the proximal contact surface of the hex nut ring 370 a when thespin nut is engages with a catheter hub, as illustrated in FIG. 15B. Inthis manner, the retainer body 130 lies between the contact surface ofthe spin nut 330 and the contact surface of the hex nut ring 370 a toinhibit longitudinal movement of the connector fitting (and the attachedcatheter hub) relative to the retainer, which is adapted to be securedto the patient. If, however, the healthcare provider positions theretainer 120 on the connector fitting at a position farther from thespin nut 330, as seen in FIG. 27J, the retainer can still receive theconnector fitting body, as well as one or both of the hex nut rings. Theinteraction between the abutment surfaces of the retainer and thecontact surfaces of the hex nut ring(s) generally arrests longitudinalmovement. In addition or in the alternative to such interaction betweenthe retainer and the hex nut ring(s), the retainer can also include anadhesive coating that covers at least a portion of the central channel1500. The adhesive coating in one preferred form releasably holds theconnector fitting to the retainer to inhibit movement of the connectorfitting relative to the fitting. Such adhesive, in other variations ofthe retainer, can more permanently attach the connector fitting to theretainer.

The various embodiments of securement devices and techniques describedabove thus provide a number of ways to provide safe and releasablesecurement for medical articles to the skin of a patient. In addition,the techniques described may be broadly applied for use with a varietyof medical lines and medical procedures.

Of course, it is to be understood that not necessarily all suchobjectives or advantages may be achieved in accordance with anyparticular embodiment using the systems described herein. Thus, forexample, those skilled in the art will recognize that the systems may bedeveloped in a manner that achieves or optimizes one advantage or groupof advantages as taught herein without necessarily achieving otherobjectives or advantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. Although thesetechniques and systems have been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that these techniques and systems may be extended beyond thespecifically disclosed embodiments to other embodiments and/or uses andobvious modifications and equivalents thereof. Additionally, it iscontemplated that various aspects and features of the inventiondescribed can be practiced separately, combined together, or substitutedfor one another, and that a variety of combination and subcombinationsof the features and aspects can be made and still fall within the scopeof the invention. Thus, it is intended that the scope of the systemsdisclosed herein disclosed should not be limited by the particulardisclosed embodiments described above.

1. A medical line securement system comprising: a medical article; at least one anchor pad including a lower adhesive surface configured to attach to an epidermal layer of a patient; and a retainer comprising, a body member having a channel formed therethrough about a channel axis, the channel being configured to retain at least a portion of the medical article and having a longitudinal access opening disposed on an underside of the body member to allow at least ingress of the portion of the medical article into the channel, at least one abutment extending generally normal to the channel axis and configured to inhibit longitudinal movement of the medical article, and at least one support disposed on the underside of the retainer and to a side of the access opening opposite the channel axis, the support attached to the anchor pad, wherein the channel is located within the body member so that a lower extremity of the retained portion of the medical article is spaced at a distance from the channel axis, the distance being less than a distance between a lower extremity of the retainer and the channel axis so as to inhibit contact between the retained portion of the medical article and a patient's skin when the retainer is placed upon the patient's skin.
 2. A medical line securement system as in claim 1 wherein the medical article comprises at least one contact surface which is configured to abut against the at least one abutment to arrest movement of the medical article in at least one direction.
 3. A medical line securement system as in claim 1 wherein the at least one abutment is located between proximal and distal ends of the body member along the axis of the channel.
 4. A medical line securement system as in claim 1 wherein the at least one abutment is a surface on a proximal end of the body member along the axis of the channel.
 5. A medical line securement system as in claim 1 wherein the at least one abutment is located on a distal end of the body member along the axis of the channel.
 6. A medical line securement system as in claim 2 wherein the at least one contact surface comprises a surface of a radially extending member.
 7. A medical line securement system as in claim 6, wherein the radially extending member extends about the circumference of the medical article.
 8. A medical line securement system as in claim 6, wherein the radially extending member extends substantially parallel to the medical article.
 9. A medical line securement system as in claim 6, wherein the retainer comprises two abutments disposed between the proximal and distal ends of the medical article to form a slot therebetween, and wherein the slot receives the radially extending member when the medical article is inserted into the channel.
 10. A medical line securement system as in claim 1 wherein the medical article is a catheter hub.
 11. A medical line securement system as in claim 1 wherein the medical article is a connector fitting.
 12. A medical line securement system as in claim 1 wherein the medical article comprises two contact surfaces, and wherein the body member of the retainer is sized to fit between the two contact surfaces.
 13. A medical line securement system as in claim 1 wherein the medical article comprises two contact surfaces and the body member of the retainer comprises two abutments, and wherein the two contact surfaces abut against the two abutments.
 14. A medical line securement system as in claim 1, wherein the channel has an arc length of greater than 180 degrees.
 15. A medical line securement system as in claim 1, wherein the channel has a first tapering shape.
 16. A medical line securement system as in claim 15, wherein an outer surface of the medical article has a second tapering shape.
 17. A medical line securement system as in claim 16, wherein the first tapering shape and the second tapering shape cooperate together when the medical article is inserted into the channel to limit longitudinal movement of the medical article in a first direction.
 18. A medical line securement system as in claim 17 wherein the medical article comprises a contact surface which abuts against the at least one abutment to limit longitudinal movement of the medical article in a second direction.
 19. A medical line securement system as in claim 1, wherein the retainer comprises a retention surface which is configured to inhibit transverse motion of the medical article.
 20. A medical line securement system as in claim 19, wherein the retention surface is located in the channel.
 21. A medical line securement system as in claim 20 wherein the retention surface provides a snap-fit securement with the portion of the medical article.
 22. A medical line securement system as in claim 20, wherein the retention surface flexes when the medical article is inserted into the channel.
 23. A medical line securement system as in claim 22, wherein the retention surface is a movable wall.
 24. A medical line securement system as in claim 20, wherein the channel has a radius of R and wherein the retention surface is located at a distance of greater than R from the axis of the channel.
 25. A medical line securement system as in claim 1, wherein the at least one support is a first mounting wing coupled to the body member and configured to attach to the at least one anchor pad.
 26. A medical line securement system as in claim 1, wherein the abutment comprises an adhesive, the adhesive adhering to the medical article when the medical article is inserted into the retainer.
 27. A medical line securement system as in claim 1, wherein a portion of the body member is transparent to facilitate alignment and ingress when inserting the medical article into the channel.
 28. A medical line securement system as in claim 9, further comprising a stop member which extends into a portion of the slot such that when the medical article is inserted into the channel and rotated in a first direction around the axis of the channel, the radially extending member slides within the slot until the radially extending member contacts the stop member.
 29. A medical line securement system as in claim 1, wherein the abutment comprises a wall of a slot.
 30. A medical line securement system as in claim 1, wherein the abutment comprises a ridge.
 31. A medical line securement system as in claim 1, wherein the abutment comprises a protuberance.
 32. A medical line securement system comprising: a medical article having a connector; a retainer comprising, a body member having a channel formed therethrough, the channel being configured to retain at least a portion of the medical article and having a longitudinal access opening disposed on an underside of the body member to allow ingress of the portion of the medical article into the channel, at least one abutment extending generally normal to an axis of the channel and configured to inhibit longitudinal movement of the medical article, at least one support surface disposed on the underside of the retainer and to a side of the access opening opposite the channel axis, the support surface being configured to support at least a portion of the body member at a distance from a patient's skin such that at least a portion of the retained medical article is held away from the patient's skin when the retainer is placed on the patient's skim wherein an overall length of the retainer is less than a length of the medical article.
 33. A medical line securement system as in claim 32, wherein the retainer further comprises at least one anchor pad including a lower adhesive surface configured to attach to an epidermal layer of a patient; and wherein the at least one support surface is configured to attach to one of the at least one anchor pads.
 34. A medical line securement system as in claim 32, wherein the medical article is a catheter hub.
 35. A medical line securement system as in claim 32, wherein the medical article is a connector fitting.
 36. A medical line securement system as in claim 32, wherein the medical article comprises at least one contact surface which is configured to abut against the at least one abutment to arrest movement of the medical article in at least one direction.
 37. A medical line securement system comprising: a medical article having a connector body with an outwardly extending member; at least one anchor pad including a lower adhesive surface configured to attach to an epidermal layer of a patient; and a retainer comprising, a body member having a channel formed therethrough about a channel axis, the channel being configured to retain at least a portion of the medical article and having a longitudinal access opening disposed on an underside of the body member to allow at least ingress of the portion of the medical article into the channel, at least two abutments extending generally normal to the channel axis and configured to abut against the outwardly extending member so as to inhibit longitudinal movement of the medical article in both longitudinal directions, wherein the at least two abutments are disposed between proximal and distal ends of the medical article and form a gap therebetween, and wherein the gap receives the outwardly extending member when the medical article is inserted into the channel, and at least one support disposed on the underside of the retainer and to a side of the access opening opposite the channel axis, the support attached to the anchor pad, wherein the medical article does not contact the patient's skin at least between the proximal or distal end and at least one of the abutments when the portion of the medical article is retained by the channel. 